Inflatable vaginal pessary

ABSTRACT

A pessary device, comprising a first inflatable chamber adapted to fit in the vestibule of the vaginal cavity of a human when inflated, wherein the chamber compresses the urethra of the human when inflated; an anchor member adapted to snugly fit in the vaginal cavity, the anchor member being connected to the inflatable chamber on the posterior side of the chamber when the pessary is in its normal operating position; and an inflation tube having a first end fluidly connected to the inflatable chamber and a second end connected to an inflation valve located external to the vagina when the pessary device is in its normal operating position that permits inflation and deflation of the inflatable chamber without disturbing the fit of the anchor member.

This application is a continuation of U.S. application Ser. No.08/434,362, filed May 5, 1995, which is a continuation of U.S.application Ser. No. 08/273,391, filed Jul. 1, 1994, now abandoned.

INTRODUCTION

1. Technical Field

The present invention relates to an inflatable vaginal pessary suitablefor treating urinary incontinence, cystoceles, rectoceles, and uterineprolapse.

2. Background

Continence, or normal control of urine retention in the bladder,involves the coordination of the bladder, bladder neck and urinarysphincter. The body stores urine in the bladder by maintaining a closedbladder neck and a contracted urinary sphincter muscle. To pass urinethe bladder contracts while the bladder neck opens and the urinarysphincter muscle relaxes.

Urinary incontinence (UI) occurs when one or more of the anatomicalstructures related to urine storage malfunctions and leads to a loss ofcontrol of urination. The most common type of incontinence is caused byhypermobility of the bladder neck and urethra due to a weakening of thetissues surrounding these structures. In females, pelvic traumaassociated with child birth is a common cause of tissue weakening.Another cause of incontinence is a deficiency in urinary sphinctermuscle control, intrinsic sphincter deficiency (ISD). It is estimatedthat approximately 8.5 million women suffer from UI in the UnitedStates. Up to 75% of female nursing home patients experience some degreeof urinary incontinence, creating a tremendous economic, as well ashygienic, burden.

Female incontinence is currently treated using devices, surgicaltechniques, behavioral techniques and pharmaceuticals. Devices used totreat female incontinence include absorbent pads, in-dwelling or Foleycatheters, vaginal pessaries (U.S. Pat. Nos. 5,224,494, 5,007,894,4,139,006, 3,554,184, and 3,554,184), solid continence rings (such asthe Cook™ or Suarez continence rings), injected or implanted materials(such as Contigen™, based on collagen), the American Medical Servicesinflatable 800 artificial urinary sphincter, and inflatable urethralplugs (such as Reliance™). Surgery to correct hypermobility of theurethra and bladder neck, behavioral therapy, and drugs that act onbladder neuronal control are also used to combat female incontinence.

The currently available inflatable vaginal pessaries for femaleincontinence do not sufficiently control incontinence in a comfortable,convenient fashion. U.S. Pat. Nos. 5,007,894 and 5,224,494 discloseinflatable donut-shaped devices. The donut-shaped device of U.S. Pat.No. 5,007,894 when Mated in the vagina transmits inter-abdominalpressure during a stress condition, such as coughing, to the upperurethra. The device has two projections on the donut shaped body toposition the device on either side of the urethra in the vaginal cavity.When the donut is inflated it remains in place along the vaginal walland is deflated for removal. The device of U.S. Pat. No. 5,224,494 is asimilarly shaped donut with an additional, long, retractable inflationtube that does not protrude outside the body cavity. The device of U.S.Pat. No. 3,646,929 is an inflatable diaphragm coupled to an elongatedsolid support that is inserted into the vagina. These devices aredifficult to insert into the vagina, uncomfortable to wear, and notlikely to stay in place; furthermore they inadequately preventincontinence or leakage of urine.

Weakening of the pelvic tissues can also result in prolapse of theuterus, bladder, rectum, or intestines. Vaginal pessaries can be used asa mechanical barrier to prevent the extrusion of these organs throughthe introitus. Devices such as those discussed above can be used totreat prolapses but suffer from many of the drawbacks as discussed forincontinence.

OBJECTS OF THE INVENTION

One object of the present invention is an inflatable vaginal pessarythat controls female incontinence more conveniently and comfortably thanprevious incontinence devices.

Another object of the invention is a vaginal pessary that need not beremoved in order for the user to urinate; instead urination iscontrolled by easily operable valves that regulate the inflation leveland pressure of the pessary.

A further object of the invention is a vaginal pessary that remainsanchored in the vaginal cavity during movement, such as coughing orexercise, and urination.

Still another object of the present invention is a vaginal pessary thatpermits the user to control separately (1) the degree of anchoring orsnugness of fit of the pessary in the vaginal cavity and (2) the abilityto urinate.

Another object of the invention is a vaginal pessary that maintainssufficient stiffness when deflated so that it is easily inserted intothe vaginal cavity, similar to a tampon.

A further object of the invention is to provide different embodiments ofa vaginal pessary, both one that can remain in place for days and onethat is disposable.

A still further object of the invention is a vaginal pessary that can beused to treat cystoceles, rectoceles, uterine prolapse or vaginalprolapse.

SUMMARY OF THE INVENTION

The objects of the invention, both those noted above and other objectsthat will be apparent in the following detailed description of theinvention, have been accomplished by providing a pessary devicecomprising a plurality of separately inflatable chambers adapted tosnugly fit in a vaginal cavity when inflated. The vaginal pessary ismade of multiple inflatable chambers adapted to snugly fit in a vaginalcavity when inflated. Inflatable chambers can be either empty whencollapsed or can contain an expandable material that assists inflation.At least one chamber is an inflatable chamber that compresses theurethra when inflated. The compression produced by the device reducesthe cross sectional area of the urethra lumen. Preferably, the deviceexerts sufficient pressure against the tissues surrounding the urethrato compress the urethra lumen to the point where no urine leaks outduring movement. Inflation of at least one chamber is controlled by aninflation valve or valves fluidly connected to the chamber, typicallyvia a central inflation channel. One valve separately controls deflationand inflation of at least one inflatable chamber during removal andinsertion of the device; the same or a different valve controlsinflation of a chamber that controls urination. Urination does notrequire removal of the pessary because the chamber that controls urethracompression is separately operated and inflated from the posteriorchamber (or chambers) that controls the anchoring of the device in thevaginal cavity. In another embodiment a non-inflatable posterior member,such as a diaphragm, replaces the posterior chamber used for anchoring.The device can also be used to treat cystoceles, rectoceles, uterineprolapse or vaginal prolapse in a female human by inserting device intothe vagina and inflating at least one chamber to prevent tissueintrusion into the vagina.

Another aspect of this invention is a kit for a pessary comprising avalved pessary with a separate fluid pump compatible with the valves onthe pessary. Incontinence can be treated by inserting the pessary intothe vagina and using the separate pump to inflate at least one chambersufficiently to compress the urethra and prevent the flow of urine.

The vaginal pessary of the invention is easy to insert and remove fromthe vaginal cavity, because of its inflatable nature.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sagittal view of a body cavity showing a vagina with avaginal pessary of the invention inflated in the vagina.

FIG. 2 is a plan view of one embodiment of the vaginal pessary.

FIG. 3 is a plan view of a second embodiment of the vaginal pessary.

DESCRIPTION OF SPECIFIC EMBODIMENTS

The invention is most easily understood by considering an embodiment ofthe invention in relation to the anatomy of the vagina and urinary tractas shown in FIG. 1. The device is generally inserted into the vaginawhile partially deflated or deflated. Insertion is similar to that for atampon. Once inside the vagina the device is inflated to secure thedevice with a snug fit against the walls of the vagina and to compressthe urethra. FIG. 1 shows an inflated, two-chambered, rust embodiment ofthe invention with an anterior chamber 20 that snugly fits into thevestibule 1 (anterior region of the vagina) to compress the urethra 2when inflated and a posterior chamber 30 that snugly fits into thefornix 3 (posterior region of the vagina) when inserted and inflated. Inthis embodiment an inflation channel 10 provides separate, fluidconnections to each chamber so that each chamber can be separatelyinflated. A first inflation valve 40 fluidly connects the anteriorchamber 20 to the atmosphere or a fluid pump. A second inflation valve41 fluidly connects the posterior chamber to the atmosphere or a fluidpump. Also shown in FIG. 1 are various structures of the pelvic region,including the bladder 4, pubic bone 5, rectum 6, coccyx 7 and uterus 8,in order to show the positioning of the pessary in its normal operatingposition relative to the organs of the body.

The inflatable vaginal pessary of the invention can be used to treatmedical conditions related to the weakening of pelvic tissues, such as,but not limited to, incontinence, cystoceles, rectoceles, uterineprolapse and vaginal prolapse.

Generally, the vaginal pessary is made of a plurality of inflatablechambers adapted to snugly fit in a vaginal cavity when inflated. Atleast one chamber is an anterior chamber (located anteriorly in thevagina) and acts to compress the urethra when inflated. At least oneadditional chamber, or in the alternative a non-inflatable anchoringmember, is a posterior chamber or member (i.e., located posteriorly inthe vagina) used to secure or anchor the device in the vagina wheninflated or inserted. Inflatable chambers can be empty when compressedor can contain an expandable material (e.g., an elastic foam) to assistexpansion. Expandable materials include but are not limited topolyurethane foam, polymeric elastomers and natural fibers. Usually allinflatable chambers are fluidly connected to a valve that controlsaccess to the atmosphere or a fluid pump. However, this is not necessaryto practice the invention when a slowly expandable material is used toinflate the posterior chamber. If an expandable material is used insidethe chamber, the material is compressed when the device is beinginserted into the vagina. Once inside, the vagina the expandablematerial expands to snugly fit the inflatable chamber inside the vagina.A chamber containing an expandable material is considered to be"inflatable" as this word is used to describe the present invention. Ifthe expandable material tends to expand rapidly when pressure isreleased, it is preferred to control access of air to the chambercontaining the expandable material with a valve for better control ofexpansion. The valve is open while air is being expelled and the chambercompressed, closed to prevent expansion while the pessary is beinginserted, and then opened again to allow expansion of the chamber.

Chambers filled with expandable materials do not require a pump forinflation. Empty chambers are filed using a pump to inject a fluid(usually air or water) into the chamber. The pump can either be builtinto the pessary or can be separate and adapted for connection to thepessary via the valve that controls inflation. Such pumps are discussedbelow in more detail.

Multiple chambers can be used in place of either the anterior orposterior chamber of the two-chamber device shown in the rust embodimentto either compress the urethra or to anchor the device in the vagina orboth. As used in this specification, a single "chamber" is an interiorspace that can be separately inflated and deflated. A single chamber canhave internal walls or baffles, but such a chamber is still "single" ifit can be inflated through a single valve. If multiple chambers are usedto compress the urethra, the shape and total volume of the set ofanterior chambers will usually correspond to the shape and total volumeof the anterior chamber used individually in a two-chamber device asshown in FIG. 1. Similarly, if multiple chambers are used to function asan anchor, the shape and total volume of the set of anchor chambers willusually correspond to the shape and volume of the anchor chamber usedindividually in a two-chamber device. Two-chamber devices are preferredfor their ease of operation.

In another embodiment of the invention, only one chamber, the anteriorchamber, is inflatable, and the device is secured in the posteriorregion of the vagina by a non-inflatable posterior member. In thisembodiment the posterior member is preferably adapted in the shape of acontraceptive diaphragm to snugly fit in the fornix. Generally, acircular shaped diaphragm 70 will be used. The inflation channel oranother central member that provides rigidity for insertion of thepessary, as discussed below, preferably attaches in the center of thediaphragm in this embodiment.

Each inflatable chamber of the pessary is adapted to snugly fit in thevagina when inflated in its normal operating position. When inflated,the anterior chamber presses against the walls of the vagina withsufficient pressure to compress the urethra. When inflated, theposterior chamber presses against the vaginal walls with sufficientpressure to prevent accidental dislocation of the pessary from or withinthe vaginal cavity. Generally, the pressure of an inflated posteriorchamber will vary from 0.1 to 5.0 atmospheres greater than ambient airpressure, and preferably 0.10 to 3.0 atmospheres. Generally, an inflatedanterior chamber pressure will vary from about 1 to 2.5 times thatdisclosed for a posterior chamber. In treating UI a greater anteriorchamber pressure, compared to the posterior chamber pressure, willgenerally be required. Generally, posterior chambers inflate to amaximum volume 50% to 500% greater than their deflated volume. Themaximum inflated volume of a posterior chamber will vary from about 40cc for a small chamber (child) to 500 cc for a large chamber (largeadult), preferably from 60 cc to 200 cc and most preferably from 80 ccto 120 cc. The anterior chamber is preferably adapted to snugly fit inthe vestibule. Generally, anterior chambers inflate to a maximum volume0% to 100% greater than their deflated volume. The maximum inflatedvolume of an anterior chamber will vary from about 10 cc for a smallchamber to 150 cc for a large chamber, preferably from about 30 to 100cc and most preferably from about 40 to 90 co. The posterior chamber ispreferably adapted to fit the fornix. However, there need not be anexact correspondence between the functional (anterior and posterior)chambers of the device and these anatomical descriptions (which indeeddo not describe a sharp anatomical change, but rather a gradual one).Thus the anterior chamber of a pessary of the invention can extend intothe fornix region or the anchor member (posterior chamber) can extendinto the vestibule region, as long as the other essential features ofthe invention are present in the device.

In some embodiments an inflation channel is provided for fluidconnections between chambers and inflation valves. In such embodimentsat least one inflatable chamber is attached and fluidly connected to aninflation channel with an inflation valve. "Fluidly connected" refersherein to a connection that permits the passage of a fluid such as (butnot limited to) air or water between a chamber and an inflation valvelocated outside the body cavity when the device is properly inserted.Chambers can be inflated through the inflation channel sequentially, inparallel or independently. Independent inflation (separate inflation) ofchambers is preferred for two-chambered devices. If more than twochambers are used, it is preferred to inflate chambers located in theanterior region of the vagina independently from chambers located in theposterior region of the vagina. FIG. 2 shows independently inflatableanterior and posterior chambers (20 and 30, respectively). Each chamberis independently inflatable using inflation channel 10. To accomplishindependent inflation, a first inflation valve 40 is fluidly connectedto a first inflation opening 50 located inside the anterior inflatablechamber 20; a second inflation valve 41 is fluidly connected to a secondinflation opening 51 located inside the posterior chamber. Arrow 43indicates inward fluid flow in a first tube fluidly connecting a firstinflation valve 40 with anterior chamber 20. Arrow 42 indicates inwardfluid flow in a second tube fluidly connecting a second inflation valve41 to the posterior chamber.

FIG. 3 shows an inflatable anterior chamber and a non-inflatableposterior member (20 and 70; respectively). The anterior chamber isinflated using inflation channel 10. A first inflation valve 40 isfluidly connected to a first inflation opening 50 located inside theanterior inflatable chamber 20. Arrow 43 indicates inward fluid flow ina first tube fluidly connecting a first inflation valve 40 with anteriorchamber 20.

Separate inflation of the anterior and posterior chambers permits eachchamber to be individually and snugly fit to two different regions ofthe vaginal cavity. Thus, the posterior chamber can be inflated to aradius of sufficient size to anchor the device in the posterior regionof the vagina, and the anterior chamber can be separately inflated tocontrol incontinence and separately deflated to permit urination. Theinflated diameter (or similar cross sectional dimension) of theposterior chamber is not necessarily larger than (or even as large as)the anterior chamber. For instance, if the posterior chamber ispartially inflated, yet firmly held in place, the anterior chamber'sfully inflated diameter may be greater to achieve complete compressionof the urethra lumen. Preferably, the anterior chamber has a fullyinflated diameter less than or equal to the fully inflated diameter ofthe anchoring chamber. When the anterior chamber is properly inflated itprevents urinary leakage by exerting sufficient pressure against thevaginal wall in the vestibule to compress the urethra.

The sizes of each chamber can vary greatly depending on the dimensionsof the vaginal cavity of the user. Preferably, the anterior chamber willbe 3 to 7 cm in length, preferably 4.0, 5.0 or 6.0 cm in length, asmeasured along the longitudinal axis of the inflation tube. The fullyinflated cross-sectional dimension (diameter) of the anterior chambercan range from 0.5 to 6 cm across, and is preferably, 4.0 to 5.0 cmacross. The posterior chamber can range from 0.5 to 4 cm in length, andis preferably 2.0 to 3.0 cm in length. The fully inflater crosssectional dimension (diameter) of the posterior chamber can range from0.5 to 10 cm across, and preferably, 3.0 to 6.0 cm across. If multiplechambers are used in either the fornix or the vestibule, the aggregatelengths, cross sectional dimensions and volumes of those chambers shouldapproximate the lengths, cross sectional dimensions and volumesdisclosed for posterior and anterior chambers, respectively, of thetwo-chambered pessary.

The shapes of the chamber can vary greatly depending on the contours ofthe vaginal wall anatomy and application (for example, simpleincontinence versus vaginal prolapse). The chambers can be adapted tofit the vaginal cavity by using a shape that can be, but is not limitedto, one or a combination of the following shapes: cylinder, discus,sphere, rectangle, dumbbell and ellipse. Preferably, the anteriorchamber is shaped like a cylinder or ellipse. Variance in user anatomymay require compression of a specific area of the urethra in which casethe anterior chamber can also have surface protrusions, solid orinflatable, on a surface of an inflatable chamber. Protrusions provide amore focused pressure point when the chamber is inflated. If theposterior chamber is formed as a discus or dumbbell, preferably thelongest dimension of the posterior chamber is perpendicular to thelongitudinal axis of the pessary. It will be recognized that themanufactured shapes are not likely to be exactly those of thegeometrical shapes but will be approximate and are likely to haverounded edges.

For some devices, particularly those used in a reusable fashion (wherethe device remains inserted in the vagina for days and can be reused),the device preferably has a means for draining the vagina of vaginalsecretions, such as a channel leading through the chambers to theoutside of the body cavity. Preferably, the anterior and posteriorchambers have a drainage surface groove or grooves 60 to allow fordrainage of vaginal secretions. These grooves are preferably located onthe dorsal side (the side closer to the vertebrae) of the device wheninserted in its normal manner.

The inflation channel, when present, provides at least one fluidconnection that connects at least one chamber to a correspondinginflation valve. The fluid connections are typically in the form of atube or other form of independent fluid passageway. Thus the fluidconnections are often referred to herein as "inflation tubes," eventhough the fluid connection is not necessarily in the shape of a tube.The "tube" thus represents whatever shape is present to connect thechamber to the valve and may merely be the end of the chamber itself(e.g., for the anterior chamber that is adjacent to the external openingof the vagina) or an extension thereof. Fluid connections separatelyconnecting each inflation valve to each chamber are preferred. Theindividual fluid connections can be bundled in the inflation channel.One or more openings in the inflation channel allow individual fluidconnections to be made to the individual chambers. One end, referred toas the "first end," of each fluid connection is fluidly connected to achamber. An inflation valve, when a valve is used, is attached to thesecond end of the fluid connection. The second end is anterior to thefirst end when the device is inserted into the vagina, and the secondend and/or valve is normally located outside the vagina when the pessaryis in use. In view of the broad meaning of inflation tube, it should beapparent that the two "ends" of the inflation tube may merely be the twosides of the chamber/valve junction if the valve is directly attached toa chamber, as occurs is some embodiments.

The inflation channel in some embodiments also acts as a base or supportfor a chamber or chambers. In such cases the inflation channel ismanufactured to provide sufficient axial rigidity to permit convenientand slidable insertion of the pessary into the vagina. Each chamber isattached at a site on the longitudinal axis of the inflation channelthat corresponds to the correct anatomical regions of the vagina whenthe device is inserted into the vagina. Inflatable chambers can beattached to the inflation channel in a molded fashion or using anadhesive, such as a silicone adhesive.

A chamber can be attached to the inflation channel on one or more sidesof the inflation channel. A chamber is preferably attached radially tothe inflation channel to minimize contact of the inflation channel withthe walls of the vagina. Preferably a chamber is symmetrically andradially attached to the inflation channel. More preferably a chambersurrounds the inflation channel along its longitudinal axis and iscontiguously attached to the inflation channel. Contiguously attached asused herein means attached without interruptions. When a cylindricalshape is used for a chamber, the chamber is preferably attachedcontiguously to the inflation channel at the ends of the cylinder tohelp maintain the cylindrical shape when in use.

Fluid connections need not take place through a central inflationchannel as shown in the embodiment of FIG. 1; instead they can beentirely separate from each other if desired. In such cases the functionof the central inflation channel as a support member for providingrigidity to allow ease of insertion of the pessary can be provided by asupport member that does not make any fluid connections. Alteratively, acentral support member is not required in some embodiments if othermeans are provided for inserting the pessary into the vagina. Forexample, a disposable sheath or other insertion device (such as thosecommonly used in the tampon art) can be used with anun-inflated/un-expanded pessary, followed by inflation or expansion ofthe anchor member after removal of the insertion device.

In the two-chamber embodiment, chambers are preferably separatedaccording to the dimensions of the vagina in which the device will beused. The larger the separation between vestibule and the fornix, thelarger the separation between the two chambers for a comfortable fit.However, no separation is necessary between the two chambers. Preferablythe separation distance along the longitudinal axis of the inflationchannel is less than 1 cm, but could be as great as 2 to 3 cm or longer.

The inflation channel is designed according to the type of chamberinflation that is desired, such as parallel or separate inflation, asdiscussed herein. If two chambers are used with separate inflation, theinflation channel is preferably made of a support tube adapted toprovide attachment sites for the anterior chamber and the posteriorchamber, a first inflation tube fluidly connected to the anteriorchamber and adapted to fit inside the support tube, and a secondinflation tube fluidly connected to the posterior chamber and adapted tofit inside the support tube.

The diameter of an inflation channel will vary according to the size ofthe user. Generally, the outside diameter of the inflation channel willvary from about 0.4 cm to 2.0 cm, and preferably from about 0.8 to 1.5cm. The internal diameter of an inflation tube will generally vary fromabout 0.1 cm to 1 cm, and preferably from about 0.2 to 0.6 cm.Alternatively, the inflation channel can be configured as a tube havingtwo separate channels separately and fluidly connected to the anteriorand posterior chambers. In this embodiment it is preferred that the twochannels of the tube are formed in one molded piece.

In preferred embodiments, each inflation tube is connected to aninflation valve to permit inflation of the chambers. The inflation valvecomprises at least one valve that controls the passage of fluid into achamber or chambers. Preferably, two valves are used, a first valve tocontrol fluid flow through a first inflation tube to the anteriorchamber and a second valve to control fluid flow through a secondinflation tube to the posterior chamber. To maximize comfort and ease ofoperation, the first and second valves are preferably located outsidethe body cavity when the pessary is placed inside the vaginal cavity. Tofurther make the valves easy to manipulate, especially for patients withcompromised manual dexterity, the valves are preferably coded by feel(such as texture, size, or shape). The valves can also be coded bylettering or color, or by any combination of coding types. Valves can beattached to the inflation tubes by methods known in the art, such asadhesive or molding.

The valves used to control fluid flow should preferably be easy tooperate, preferably by the fingers of the user. Many such valves areknown in the art, for example, Luer lock valves, one-way fluid valves,or Foley catheter valves. To allow for inflation, the valves arecompatible with a fluid pump as known in the art, such as a syringe, aone-way air valve pump, a basketball shoe pump, a compressed aircanister, a compressible fluid reservoir (such as compressible rubberbladder that engages with the valve) or a piston pump. The pumps can bemade an integral part of the pessary or can be separate, as describedbelow in more detail.

The pessary can be made either for reuse or disposal after a single orlimited number of uses. Disposable pessaries are preferably disposedafter 1 to 14 days, more preferably after 1-7 days, and most preferablyafter 1-2 days. Both reusable and disposable pessaries are generallyworn for 1 to 36 hours, preferably not longer than 12 to 15 hours. Apessary is generally washed (e.g., with soap and water) after use andbefore re-insertion.

The pessary can be made of a variety of biocompatible materials, i.e., amaterial that minimizes the reaction of the body resulting from contactof the material with the vaginal wall and provides for a comfortablefeel and fit by the user. The manner in which the device is intended tobe used, whether reusable or disposable, will determine in part whattype of material is preferred. Vaginal pessaries that are reused arepreferably made from material that is more resistant to degradation bymechanical movement, bodily fluids, cleaning procedures, and oxidationthan disposable vaginal pessaries. If the vaginal pessary is used with alubricant to ease insertion, the biocompatible material should becompatible with that lubricant.

Various biocompatible materials can be used, for chambers or othermembers, such as silicone (for instance, silicone elastomers, such aspoly-dimethyl siloxane), latex, polyurethane, polyethylene, balloonangioplasty materials, Silastic™, and teflon-coated latex. Thebiocompatible material used for a chamber can be an elastic material ora non-elastic, flexible material. A non-elastic, flexible materialprovides for a maximum, inflated cross sectional dimension (such asdiameter) of the chamber. In order to provide for maximum comfort andincontinence control, each chamber can be made of a differentbiocompatible material or different regions of a chamber can be made ofa different biocompatible material. For example, the anterior chambercan be made of a non-elastic, or less distensible, flexible materialappropriately sized for urethra compression when inflated and theanchoring chamber can be made of a elastic material that can inflate toa more variable range of sizes inside the fornix region of the vagina toprovide for a secure fit when encountering different abdominal pressureswhen the user stands or lies down.

The inflation channel is also made of a biocompatible material. Suitablematerials for the inflation channel include silicone (for instance,silicone elastomers, such as poly-dimethyl siloxane (but stiffer thanthat used for chambers)), latex, polypropylene, polyethylene, andteflon-coated latex. As discussed herein the inflation channel (or othercentral member) is flexible to conform to the shape of the vaginalcavity while being rigid enough to provide support for the chambers andto direct the insertion of the device into the vagina. It will also beappropriate in various embodiments for the tip of the inflation channelto be made as a solid tip to aid insertion of the device into thevagina. The inflation channel can be made of different materials in itsdifferent component parts to maximize the comfort of the user whilewearing the device. For instance, the portion of the inflation channelthat extends past the vaginal cavity can be made more flexible and lessrigid than the material used for the portion of the inflation channelinside the vaginal cavity. This permits the portion of the inflationchannel outside the body to be more easily stored.

The invention also includes a method of treating incontinence in afemale human. To treat incontinence, a pessary of the invention isinserted into the vagina. Preferably the pessary is adapted so that thepessary can be inserted in a tampon-like fashion. At least one chamberis adapted to snugly fit in a vaginal cavity. To control incontinence atleast one inflatable chamber is inflated with sufficient pressure tocompress the urethra and prevent the flow of urine. To anchor thepessary in the vagina at least one posterior chamber is inflated orinserted (i.e., in the diaphragm embodiment). If the method is used witha non-inflatable chamber, it is preferable to use a non-inflatablechamber similar in shape and dimensions to a contraceptive diaphragm. Ifthe users require day-to-day vaginal care it is preferable to usedisposable pessaries.

The invention also includes a method of treating cystoceles, rectoceles,uterine prolapse or vaginal prolapse in a female human. To treat thesemedical conditions a pessary of the invention is inserted into thevagina. At least one chamber of the device is inflated to prevent tissueintrusion into the vagina. To treat uterine prolapse a larger inflatableposterior chamber, compared to that used to treat incontinence, willhelp prevent the intrusion of uterus into the vagina. Generally, theposterior chamber may require a large diameter in order to treat acystocele, rectocele or uterine prolapse.

The invention also includes a kit comprising a pessary and a fluid pumpadapted to the inflation valve (or valves) used to inflate and deflatethe pessary. The components of the kit are typically provided in acontainer that can be adapted to hold the individual components. The kitcan further include a biological lubricant, such as K-Y jelly.

The invention now being fully described, it will be apparent to one ofordinary skill in the art that many changes and modifications can bemade thereto without departing from the spirit or scope of the appendedclaims.

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

I claim:
 1. A pessary device comprising:(a) an inflatable anteriorchamber adapted to fit in a vestibule of a vaginal cavity of a humanwhen inflated, wherein said inflatable anterior chamber compresses aurethra of the human when inflated, (b) an inflation tube having a firstend fluidly connected to said inflatable anterior chamber and a secondend having an inflation valve that permits inflation and deflation ofsaid inflatable anterior chamber, said inflation tube being sufficientlyflexible to conform to the vaginal cavity and sufficiently rigid toprovide support for said inflatable anterior chamber and upon insertionof said pessary device, and (c) an anchor member comprising anon-inflatable posterior member adapted to anchor the device in aposterior region of the vaginal cavity, said anchor member beingposteriorly connected to said inflatable anterior chamber when saidpessary device is in its normal operating position.
 2. The pessarydevice of claim 1, wherein said pessary further comprises a centralsupport member and said inflatable anterior chamber circumscribes and iscontiguously attached to said central support member.
 3. The pessarydevice of claim 2, wherein said support member forms an inflationchannel comprising a support tube adapted to provide attachment sitesfor said inflatable anterior chamber and said posterior chamber; saidinflation tube fluidly connected to said inflatable anterior chamber andadapted to fit inside said support tube.
 4. The device of claim 1,wherein said inflation valve is a Luer lock valve.
 5. The pessary deviceof claim 1, wherein said inflation valve comprises afluid-pump-compatible valve.
 6. The pessary device of claim 5, whereinsaid fluid-pump-compatible valve is selected from the group consistingof a syringe valve, a one-way valve air pump valve, a compressed aircanister valve, a fluid bladder valve and a piston pump valve.
 7. Thepessary device of claim 1, wherein said inflatable anterior chamber ismade of an elastic material or a non-elastic, flexible material.
 8. Thepessary device of claim 7, wherein said inflatable anterior chamber ismade of a material selected from the group consisting of silicone,latex, polyurethane, polyethylene and polytetrafluoroethylene-coatedlatex.
 9. The pessary device of claim 1, wherein said pessary device hasat least one drainage surface groove on said inflatable anterior chamberto allow for drainage of vaginal secretions on an external surface ofsaid pessary device.
 10. The pessary device of claim 1, wherein saidanchor member is shaped similar to a contraceptive diaphragm.
 11. Thepessary device of claim 10, further comprising a central member attachedat the center of said anchor member.
 12. A kit comprising:the pessarydevice of claim 1, a fluid pump adapted to fit the inflation valve ofsaid pessary device, and a container adapted to contain said pessarydevice and said fluid pump.
 13. The kit of claim 12 further comprising abiocompatible lubricant.
 14. A method of treating incontinence in afemale human with a urethra., comprising:inserting the pessary device ofclaim 1 into a vagina of said human, and inflating said inflatableanterior chamber of said pessary device sufficiently to compress theurethra of said human and prevent urine flow.
 15. The method of claim14, further comprising deflating said inflatable anterior chamber toallow said human to urinate and re-inflating said inflatable anteriorchamber after urination.
 16. A method of treating cystoceles,rectoceles, uterine prolapse or vaginal prolapse in a vagina of a human,comprising:inserting the pessary device of claim 1 into the vagina ofsaid human, and inflating the chamber of said pessary to prevent tissueintrusion into the vagina.